Studies

What is a Study?

A Clinical Trial is the scientific term for a test or study of a drug or a medical device (defined as any treatment not ingested by the body) which is carried out with people as subjects. Clinical trials are conducted to see if the treatment is safe and effective for people to use: To see how it compares to existing treatments, or to measure its effectiveness if no current treatment exists.

What is research?

Why Volunteer?

By taking part in a clinical trial, you will try a new treatment that may or may not be better than those that already exist. But your participation also may lead to eventual improvements in the health of many other patients. To better understand how the treatments may work on different races and genders, it is important that both males and females of diverse ethnic groups, including African Americans, Hispanics/Latinos, American Indians, Asians, Pacific Islanders, and Caucasians, take part in the studies.

What Happens in a Clinical Trial?

Doctors and other health professionals run the tests according to strict rules set by the Food and Drug Administration (FDA) to make sure that people who agree to be in the studies are treated as safely as possible. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment or the standard treatment or a placebo (an inactive substance that looks like the drug being tested). By using this “blind” test method, no outside influence can affect the patient’s reaction to the treatment.

Informed Consent

To help you decide if you want to participate in a study, FDA requires that you be given complete information about the study before you agree to take part. This is known as informed consent. FDA requires that people be told:

  • This study involves research of an unproven drug or device
  • What is the purpose of the research
  • How long the study will take
  • What will happen in the study and which parts of the study are experimental
  • Possible risks or discomforts
  • Possible benefits
  • Other procedures or treatments that you might want to consider instead of the treatment being studied
  • Privacy:  FDA may look at study records, but the records will be kept secret
  • Whether any medical treatments are available in case you should be hurt, what those treatments are, where they can be found, and who will pay for the treatment
  • Person to contact with questions about the study, your rights, or if you get hurt
  • Your right to quit at any time.

Before you can be in the study, you must sign the informed consent form, showing that you have been given this information and it must be written so you can understand it. If you don't, be sure to ask the doctor or other medical person to explain it. Make sure you understand all of it before you agree to be in the study.

How Can I Find Out About Clinical Trials?

For general information about clinical trials, call FDA's Office of Special Health Issues at 301-827-4460 or visit www.fda.gov/oashi/home.html

You can also find more information at www.clinicaltrials.gov